Method of preventing covid-19 infection

ABSTRACT

A product for preventing COVID-19 infection in an individual, the product comprising a combination of vitamin C, vitamin D, and zinc. The combination comprises 1,000 mg to 10,000 mg of vitamin C, 3,000 IU to 40,000 IU of vitamin D, and 25 mg to 75 mg of zinc. The combination is administered daily for two or more days for prophylaxis, or the combination is administered weekly over a period of two or more weeks for prophylaxis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 17/114,271, titled “Method of Preventing COVID-19Infection,” filed Dec. 7, 2020, which claims priority to U.S.Provisional Application Ser. No. 63/002,494, titled “Method of UsingVitamin C, Vitamin D, Zinc, and Optionally Hydroxychloroquine, toPrevent COVID-19 Infection,” filed Mar. 31, 2020, and also claimspriority to U.S. Provisional Application Ser. No. 63/022,368, titled“Method of Using Vitamin C, Vitamin D, Zinc, and OptionallyHydroxychloroquine, to Prevent COVID-19 Infection,” filed May 8, 2020,the contents of which are incorporated by reference in their entirety.

BACKGROUND

COVID-19 is a novel betacoronavirus that originated in bats in the cityof Wuhan, China. This disease has rapidly spread to become a worldwidepandemic. Scientists have identified the molecular structure of thespike glycoproteins on the surface of the virus, which are what allowthe virus to “stick” to its target, and in this case the human lung. Thevirus has a very similar sequence and structure to the coronavirus thatcauses SARS, with the exception of the receptor binding domain. In thisdomain there is a loopy, flexible glycyl in place of a rigid prolyl,which allows it to tightly bind to a hydrophobic pocket in the receptor,ACE2.

Thus, there is a significant unmet need for preventing this viralinfection.

SUMMARY

The present invention addresses this need. The invention is directed toa method of preventing COVID-19 infection in a healthy individual, themethod comprising the steps of:

a) providing the healthy individual;

b) administering, on day 1, 1,000 mg to 10,000 mg of vitamin C, 1,000 mgto 40,000 mg of vitamin D, and 25 mg to 75 mg of zinc;

c) administering daily, on days 2 through 7, 1,000 mg to 10,000 mg ofvitamin c and 25 mg to 75 mg of zinc; and

d) repeating steps b) and c) for 1 to 23 weeks.

Optionally, step c) comprises administering daily, on days 2 and 3,10,000 mg of vitamin c and 50 mg of zinc; and administering daily, ondays 4 through 7, 3,000 mg of vitamin c and 50 mg of zinc.

Optionally, step c) comprises assessing the patient for potentialadverse events, serious adverse events, and COVID-19 symptoms.

Optionally, steps b) and c) comprise administering selenium, copper andother vitamins that are appropriate supplements for vitamin C, vitamin Dor zinc.

DRAWINGS

These and other features, aspects and advantages of the presentinvention will be better understood with reference to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a flow chart depicting the steps of a first method ofpreventing infection with COVID-19.

DETAILED DESCRIPTION OF THE INVENTION

The following discussion describes in detail one embodiment of theinvention with several variations of that embodiment. This discussionshould not be construed, however, as limiting the invention to thoseparticular embodiments. Practitioners skilled in the art will recognizenumerous other embodiments as well.

This invention describes a method of triple therapy for preventing aCOVID-19 infection.

Definitions

As used herein, the following terms and variations thereof have themeanings given below, unless a different meaning is clearly intended bythe context in which such term is used.

The terms “a,” “an,” and “the” and similar referents used herein are tobe construed to cover both the singular and the plural unless theirusage in context indicates otherwise.

As used in this disclosure, the term “comprise” and variations of theterm, such as “comprising” and “comprises,” are not intended to excludeother additives, components, integers, ingredients or steps.

The present invention is directed to a method of preventing COVID-19infection in an individual. The method comprises administering threedifferent supplements. The supplements comprise:

Vitamin C, Vitamin D, Zinc, and any mixtures thereof.

The length of preventative treatment of the present invention can be aslong as necessary. However, regardless of the length of treatment,Vitamin C is provided at 10,000 mg daily for the first three days oftreatment, and then 3000 mg daily thereafter. This 10,000 mg of VitaminC can be broken up into two doses, one taken in the morning and onetaken at night.

Vitamin D is provided at 40,000 mg one day every 4 weeks (or howevermany weeks the preventative treatment lasts). This 40,000 mg of VitaminD can be broken up into two doses, one taken in the morning and onetaken at night.

Zinc is provided at 50 mg per day ongoing, for the length of thepreventative treatment. This 50 mg of Zinc can be broken up into twodoses, one taken in the morning and one taken at night.

On Day 1 (Week 1), the patient provides verbal informed consent, thepatient reviews prior (previous 3 months) and concomitant medicationsand the patient receives the three different supplements: Vitamin C,Vitamin D, and Zinc. The patient takes 10,000 mg of Vitamin C, 40,000 mgof Vitamin D, and 50 mg of zinc.

On Days 2 and 3 (Week 1), the patient takes 10,000 mg of Vitamin C and50 mg of zinc daily. This 3,000 mg can be broken up into two 1500 mgdoses, one taken in the morning and one taken at night. The patient iscalled on the phone for assessment for potential adverse events (AE) andserious adverse events (SAE), and any COVID-19 symptoms.

On Days 4-7 (Week 1), the patient takes 3,000 mg of Vitamin C and 50 mgof zinc daily.

On Day 8 (Week 2), the patient takes 3,000 mg of Vitamin C, 40,000 mg ofVitamin D, and 50 mg of zinc.

On Days 9-14 (Week 2), the patient takes 3,000 mg of Vitamin C and 50 mgof zinc daily.

Weeks 3-24 continue with the same protocol identified above for Week 2.

During Weeks 1-23, the patient is called weekly on the phone forassessment for adverse events and serious adverse events, and anyCOVID-19 symptoms. The list of prior and concomitant medications is alsoupdated.

During Week 24, the patient is called to the clinic for evaluation toinclude assessment for potential adverse events and serious adverseevents, to update the list of prior and concomitant medications, toperform confirmatory COVID-19 testing, and to perform blood testing.

Optionally, Vitamin C dosage can range from 1000mg to 10,000mg per day,Vitamin D dosage can range from 1000 IU to 40000 IU per day, Zinc (thezinc can be any type or form of zinc) dosage can range from 25-75 mg perday. As noted above, all daily doses of Vitamin C, Vitamin D and Zinccan be broken up into two daily doses, wherein one dose is taken in themorning and one dose is taken in the evening. For all protocols providedin this application, when a dosage range is provided, any dosage amountthat is included in that range can be administered. Accordingly, theinvention is not limited to the dosage ranges disclosed, and includesall dosage amounts contained in those ranges.

The protocol provided in this application can also include selenium,copper and other vitamins that are deemed appropriate supplements forVitamin C, Vitamin D or Zinc or, to counteract the negative depletion ofcertain vitamins, like copper or selenium.

Treatment can be for one day or consecutive or repeated in 2 weeks, 1month, 6 months or 1 year.

The Vitamin C, Vitamin D and Zinc, and mixtures thereof, can beadministered orally, in the form pills/lozenges, an aerosolized spray,or a food substance such as a liquid drink or yogurt composition.Optionally, the Vitamin C, Vitamin D and Zinc can be administered in theform of a nasal spray or a topical application, such a lotion or sprayfor administration on the individual's skin.

Table 1 outlines the schedule of events for this protocol.

TABLE 1 Assessment Screening (Day 1) Day 2 Day 3 Day 4 Weeks 1-23 Weeks24/ET(±4 d) Informed Consent & Demographics X Review of Prior andConcomitant Medications X Physical Exam X Vitals^(a) X Prescription ofvitamin C, vitamin D, and zinc X Update list of prior concomitantmedications X X X Ask about AE and SAE X X X X Update dose of Vitamin Cto 3000 mg daily X Evaluation for COVID-19 symptoms X X COVID-19 testingX a. Blood draw for future testing^(b) X ^(a)Vitals to include height(only at first visit), weight, blood pressure (following 5 minutessitting), pulse, respiratory rate, temperature, and oxygen saturation.^(b)Future testing will require separate informed consent and caninclude antibody or cytokine testing.

COVID-19 sample collection period (to be conducted by patient'sphysician if infection is suspected at any time during the study orafter). Nasopharyngeal (NP) and oropharyngeal (OP) swabs will becollected according to CDC protocol—which include synthetic fiber swabswith plastic shafts. The NP swabs are collected by insertion of a swabinto the nostril parallel to the palate. The swab is left in place a fewseconds to allow it to absorb secretions. The OP swabs are inserted intothe oropharynx parallel to the palate, avoiding the tongue. The swab isleft in place a few seconds to allow it to absorb secretions. Theseswabs are immediately placed in sterile tubes with 2-3 mL of viraltransport media. The tubes are placed in biohazard bags then boxes andcouriered to the local Public Health Lab.

The above protocols can be used to prevent infection with other viruses(not just COVID-19), including other flu viruses.

The above protocols can also be used to treat Autism, Parkinson's,Alzheimer's and other neurological diseases.

EXAMPLES Example 1: Successful Treatment of COVID-19 InfectedOutpatients and Prophylaxis of Immediate Associates

Objective: to successfully treat COVID-19 infected outpatients andprophylaxis of immediate associates.

Procedure: Prospective COVID-19 infected individuals were diagnosedusing a Pangea DNA/RNA Shield™ Collection Tube to obtain anasopharyngeal swab and PCR+ve patients were entered into the study.They were immediately commenced on a 10 day course of Hydroxychloroquine(200 mg, twice a day, for 10 days), Azithromycin extended release (500mg on day 1, then 250 mg a day for days 9-10), zinc (50 mg a day fordays 1-10), Vitamin D (3000 IU a day for days 1-10) and Vitamin C (3000mg a day for days 1-10). Some individuals lived alone, otherwiseimmediate partners and family deemed to be most exposed were given aprophylactic which comprised hydroxychloroquine 200 mg twice a day onday 1 only with Zinc, Vitamin C and Vitamin D for given at the samedoses as above for days 1-10.

Results: In 11 families a total of 21 family members were identified tobe PCR COVID-19 positive index cases and were treated with the abovetreatment protocol while 22 exposed associates with negative PCR weregiven the above prophylaxis protocol. This is shown below in Table 24.All 21 index cases were cured of COVID-19 infection as judged by therepeat swab PCR on day 10 and accompanying symptom resolution. None ofthe 22 highly exposed associates developed COVID-19 infection whenretested on day 10 (day 14 in Family 10) in spite of close co-habitationwith the infected index cases. TABLE 2: Results from families received10-day course of daily HCQ (200 mg bd), AZ extended release (500 mg day1, then 250 mg), zinc (50 mg), Vitamin D (3000 IU) and Vitamin C (3000mg)

TABLE 2 After treating Age with HAZDPAC After treating (years)-Cured/PCR test ZINCD+H Patient/s sex of the Comorbiditiespositive/negative/ family member Family treated patient of the patientsother symptoms prophylaxed #1  1 23-male Asthma Negative Parents PCR-day10 overweight, diabetes, father with heart disease never got the disease#2  3 60-male Asthma All 3 patients Mother didn't (father) cured get thevirus 18-male (son) 16-female (daughter) #3  1 40-female Avoided Severmultiple Husband did not intubation by symptoms turn positive leavinghospital resolved at home #4  2 78-male BCG+COPD, Both cured Daughter,77-female diabetes, heart son-in-law and 2 disease (heart grandkidsdidn't surgery month catch the virus prior Pacemaker, BCG #5  3 56-maleUnable to Started treatment Wife never 27-male eat or drink on day 10,Sever got the disease 24-female Asthma symptoms resolved Cured #6  156-female Admitted to Husband never hospital- got the disease sent home,as two kids were sick with fever. All recovered with vitamins #7  144-female Cured, Husband and autoimmune 4 kids never issues started gotthe disease #8  3 52-female Lupus Cured Boyfriend (54 y) 53-male Severeasthma Cured with Diabetes, 19-male Cured son (18) and daughter (16)never got the disease #9  2 45-female Both cured from Husband and16-male severe symptoms daughter never of cough and fever got thedisease #10 2 44-male Cured from loss of Mother (50 y) 25-female smell,fever, cough never got 21-female Cured the disease Partially treatedwith HAZDPAC- slowly turned −ve #11 1 33-female No ICU nurse Boyfriendnever recovered got the disease

Apart from the families a further 11 single infected individuals foundto be swab PCR positive were treated with the above treatment protocol.This is shown below in Table 3. All were also successfully cured of theinfection.

TABLE 3 Age (years)- Comorbidities/ After treating sex of symptoms withHAZDPAC Patient the patient of the patients Cured/not #1  44-femaleAsthma Cured (no BCG in childhood) #2  81-male Diarrhea Cured #3 52-female Fever Cured #4  66-male Valve surgery Cured #5  29-femaleAsthma Cured (no BCG in childhood) #6  50-female Auto immunethyroiditis, Cured sever cough and fever #7  43-male Cough, desaturationof oxygen Cured #8  53-male Diarrhea, cough, fever, Cured desaturationof oxygen #9  44-female Autoimmune history, fever, Cured increase heartrate #10 44-female Pneumothorax discharged Cured from ICU with COVID-19#11 43-male Fever +ve Covid-19 PCR Cured

A further 9 individuals recently closely exposed to Covid-19 infectedpersons were given the prophylaxis protocol outlined above. Theprophylactic worked very well with no exposed person acquiring theinfection. This is shown in Table 4.

TABLE 4 Age (years) & After treating Individual details of theindividual with ZINCD+H #1 Mother of 16 year old Prophylaxed and childwho had COVID-19 never got the disease #2 24-female, ICU nurse-Prophylaxed and multiple exposures never got the disease #3 47-male,cardiologist exposed Prophylaxed and to +ve patients never got thedisease #4 70-male medical director Prophylaxed and of a hospital(exposed to never got the disease numerous doctors with COVID-19) #555-male anaesthesiologist Prophylaxed and (intubates COVID-19 patients)never got the disease #6 55-ICU nurse (worked on Prophylaxed andCOVID-19 floor) never got the disease #7 40-ICU nurse many Prophylaxedand Covid-19 patients never got the disease #8 53-Doctor withpancreatitis Prophylaxed and never got the disease #928-Paramedic-healthy Prophylaxed and never got the disease

Discussion: It was demonstrated that a 10 day combination ofhydroxychloroquine, azithromycin (for 5 days only), zinc with vitamin Dand vitamin C, can result in uniform cure of COVID-19 infection whenused in an outpatient population. The prophylaxis treatment noted abovefor those closely exposed to proven, infected patients can completelyprevent spread of COVID-19. This combination of test-and-treat permitsabolishing of new outbreaks of infection such as a ‘next wave’—byavoiding quarantine to treat the infected and give prophylactics tosurrounding staff and family.

In conclusion, this is an effective anti-Covid-19 therapy as well as aneffective prophylactic combination capable of arresting the spread ofcoronavirus infection throughout the community. This is achieved bytreating the index case and the surrounding associates of the patient asearly as possible after infection is identified and then treating thepeople they live with and close associates.

Having thus described the invention, it should be apparent that numerousstructural modifications and adaptations may be resorted to withoutdeparting from the scope and fair meaning of the instant invention asset forth herein above and described herein below by the claims.

What is claimed is:
 1. A product for preventing COVID-19 infection in anindividual, the product comprising a combination of: a) vitamin C; b)vitamin D; and c) zinc.
 2. The product of claim 1, wherein thecombination is administered weekly over a period of two or more weeksfor prophylaxis.
 3. The product of claim 1, wherein the combination isadministered daily over a period of two or more days for prophylaxis. 4.The product of claim 1, wherein the combination comprises: a) 1,000 mgto 10,000 mg of vitamin C; b) 3,000 IU to 40,000 IU of vitamin D; and c)25 mg to 75 mg of zinc; wherein the combination is administered dailyfor two or more days for prophylaxis.
 5. The product of claim 4, whereinthe combination is administered weekly over a period of two or moreweeks for prophylaxis.
 6. The product of claim 4, wherein thecombination is administered daily over a period of two or more days forprophylaxis.
 7. The product of claim 1, wherein the combinationcomprises: a) 3,000 mg of vitamin C; b) 3,000 mg of vitamin D; and c) 50mg of zinc.
 8. The product of claim 4, wherein the combinationcomprises: b) 3,000 mg of vitamin C; c) 3,000 mg of vitamin D; and d) 50mg of zinc.